Legacy Data Conversion
Delivering a seamless solution for multiple indication compound
Getting Ready for Successful Submissions
Regulation mandates that studies initiated on or after December 2016 must have standardised data, and the PMDA requires CDISC standardisation of study data for all submissions after April 1, 2020.
CDISC Service Offerings
- SDTM & ADaM Creation - adaptable to client requirements
- Legacy data conversion
- Compliance checks using Pinnacle 21 enterprise or community and in-house tools
- Study data harmonisation including coding dictionary up-versioning
- CSR gap analysis: verification of CDISC conversion by reproducing and comparing analysis produced using CDISC converted data
- e-Submission package
- Electronic Common Technical Document (eCTD) Module 5, including SDTM define.xml, SDRG, ADaM define.xml including ARM, ADRG.
- Post submission support (rapid response)
- Rescue studies